CADD SOLIS COMM MODULE
Received Nov 27, 2024 · Event occurred Nov 1, 2024
Report 3012307300-2024-14201 · MDR key 20802339
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Catalog number
21-2131-25
Lot number
19481649
Product problems
- Wireless Communication Problem
- Wireless Communication Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE SHOWS AN ERROR " WIRELESS MODULE INTERMITTENT CONNECTION WITH PUMP". THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.
Additional Manufacturer Narrative
DEVICE WAS NOT RETURNED FOR ANALYSIS FOR COMPLAINT THAT THE DEVICE SHOWS AN ERROR " WIRELESS MODULE INTERMITTENT CONNECTION WITH PUMP". HOWEVER, PHOTOGRAPHIC EVIDENCE IN COMPLAINT FILE ATTACHMENT SHOWS THE HOST PUMP FAILING WITH "WIRELESS MODULE INTERMITTENT CONNECTION WITH PUMP". WITH THE COMM MODULE NOT PHYSICALLY RECEIVED FOR EVALUATION, WE ARE UNABLE TO DETERMINE A PROBABLE CAUSE DUE TO THE INTERMITTENT NATURE OF THE FAILURE BASED ON PRIOR INTERNAL INVESTIGATION FINDINGS.